Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer.
|Anorexia Cachexia Lung Cancer||Drug: megestrol acetate Radiation: radiation therapy||Phase 3|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Phase III, Double-Blind, Randomized Study of the Effect of Megestrol Acetate on Weight and Health Related Quality of Life in Lung Cancer Patients Receiving Thoracic Radiation Therapy|
|Actual Study Start Date:||September 2000|
|Study Completion Date:||September 11, 2002|
|Primary Completion Date:||September 11, 2002 (Final data collection date for primary outcome measure)|
- Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer.
- Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to histology (non-small cell lung cancer vs small cell lung cancer), and type of treatment (radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy). Patients are randomized to one of two treatment arms.
All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks.
- Arm I: Patients receive oral megestrol once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy.
- Arm II: Patients receive oral placebo once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy.
In both arms, quality of life is assessed at baseline, at the completion of radiotherapy, and at 4, 8, 12, 16, and 20 weeks after the completion of radiotherapy.
Patients are followed at 4 and 8 weeks.
PROJECTED ACCRUAL: A total of 98 patients (49 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031785
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|